Longeveron® Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer’s Disease
Longeveron Inc. - Class A Common stock (LGVN)
Company Research
Source: GlobeNewswire
Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer’s diseaseAlignment with FDA on proposed trial study design, population and endpointsInitiation of planned pivotal Phase 2/3 clinical trial anticipated in 2H 2026, contingent upon obtaining non-dilutive funding and/or partnering supportLaromestrocel (Lomecel-B™) has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease which provides frequent interactions with the FDA, intensive guidance on drug development, and eligibility for accelerated approval and priority review MIAMI, March 20, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerati
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News
- Longeveron Inc. (NASDAQ: LGVN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $10.00 price target on the stock.MarketBeat
- Longeveron® Announces Nature Medicine Publication of Results of Phase 2a Clinical Trial Evaluating Laromestrocel (Lomecel-B™) in Alzheimer's Disease [Yahoo! Finance]Yahoo! Finance
- Longeveron® Announces Nature Medicine Publication of Results of Phase 2a Clinical Trial Evaluating Laromestrocel (Lomecel-B™) in Alzheimer’s DiseaseGlobeNewswire
- Longeveron® to Present at the 37th Annual Roth ConferenceGlobeNewswire
- Longeveron Inc. (NASDAQ: LGVN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $10.00 price target on the stock.MarketBeat
LGVN
Earnings
- 11/12/24 - Beat
LGVN
Sec Filings
- 3/28/25 - Form S-3
- 3/14/25 - Form 8-K
- 3/6/25 - Form 4
- LGVN's page on the SEC website